BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3943898 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23230
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE VERIFIED AND THE CAUSE COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FIBER INSIDE OF A TOTAL PARENTERAL NUTRITION SOLUTION BAG. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, THE REPORTER STATED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421276 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 13A17V242

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PARENTERAL NUTRITION